EP3122231B1 - Dispositif pour le réglage de la pression interne du corps lors de l'utilisation d'une pompe médicalisée - Google Patents

Dispositif pour le réglage de la pression interne du corps lors de l'utilisation d'une pompe médicalisée Download PDF

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Publication number
EP3122231B1
EP3122231B1 EP15720586.5A EP15720586A EP3122231B1 EP 3122231 B1 EP3122231 B1 EP 3122231B1 EP 15720586 A EP15720586 A EP 15720586A EP 3122231 B1 EP3122231 B1 EP 3122231B1
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Prior art keywords
pressure
fluid
software
pump
medical device
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EP15720586.5A
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German (de)
English (en)
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EP3122231A1 (fr
Inventor
Andreas ZEYSSIG
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WOM World of Medicine GmbH
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WOM World of Medicine GmbH
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3474—Insufflating needles, e.g. Veress needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3337—Controlling, regulating pressure or flow by means of a valve by-passing a pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3355—Controlling downstream pump pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/08—Limbs
    • A61M2210/086—Legs

Definitions

  • the present invention relates to a method for regulating the body pressure, e.g. B. the joint pressure when using a medical fluid pump and a device for performing the method.
  • fluids e.g. B. gases or liquids in and out of the body.
  • Arthroscopy in which the knee is rinsed with a rinsing fluid, for example as part of a knee joint examination or a therapeutic treatment, may be mentioned here as an example.
  • Another exemplary treatment is laparoscopy, in which gases (e.g. CO 2 ) are introduced into the interior of the body during a therapeutic intervention.
  • gases e.g. CO 2
  • US 2012/0283691 A1 describes an infusion system for intravascular infusion of liquids with automatic detection of a blockage in the infusion line.
  • US 2015/0085799 A1 describes a fully automatic device for medical emergencies, which should be operated by non-specialists, including an electronically controlled ventilation unit.
  • US 2010/0094113 A1 describes an automatic analysis system for checking blood components (eg blood glucose content) while monitoring blood pressure.
  • blood components eg blood glucose content
  • the disclosed method is essentially based on the fact that a mathematical model in the manner of a Kalman filter is used to measure and regulate the body pressure.
  • a mathematical model in the manner of a Kalman filter is used to measure and regulate the body pressure.
  • the entire system consisting of pressure regulator, pump motor, supply line, pressure sensor, medical supply device (e.g. trocar with optics), body cavity and fluid outlet (e.g. suction device) is described by a set of differential equations and summarized in a so-called state space model.
  • the parameters of the model are determined with sufficient accuracy, an estimate for the sensor pressure and the pressure inside the body is obtained with the same input variable. By comparing the actual and the estimated sensor pressure, deviations (so-called observer errors) can be detected.
  • the disclosed method is designed such that the estimation system is implemented as a Kalman filter.
  • Kalman filters are e.g. explained in control engineering textbooks. They allow weighting matrices to be taken into account, which represent system noise (caused by parameter fluctuations, tolerances, etc.) and / or measurement noise (interference, inadequacies of the sensors, etc.). This improves the accuracy with which the model maps the real system.
  • the type of Kalman filter can be continuous or time-discrete and applies to linear and non-linear systems.
  • a special embodiment of a device that implements the method described above is a peristaltic peristaltic pump, as is used, for example, in arthroscopy.
  • This contains an adjustable motor, which provides the peristaltic pumping power.
  • the pumped liquid is led into the inside of the body (e.g. the knee joint) via a supply line (e.g. tubing and a trocar with optics).
  • a drainage from the knee joint takes place through a second line, either in the form of a simple drainage line or in the form of a suction pump connected to the line.
  • the actual pressure in the joint is estimated using the measurement data from the pressure sensor and regulated by the pump motor.
  • An alternative embodiment of the invention consists in an insufflator as used for laparoscopy.
  • a gas is passed through the insufflator into the inside of the body (e.g. the abdomen).
  • the gas outflow from the inside of the body is also realized here, for example, by means of a suction line.
  • a pressure measurement in the feed line also takes place here.
  • the actual pressure inside the body is estimated by the method according to the invention and serves to regulate the insufflator. As a result, a device is obtained which enables precise measurement and control of the pressure even under extreme conditions, e.g. B. guaranteed when switching on or off a suction device.
  • Figure 1 schematically shows the therapist's wish: A direct, error-free pressure measurement in the joint regulates a pump that ensures the fluid flow into the joint. Because such a direct Pressure measurement is practically not possible, describes the Figure 1 just the intended goal.
  • Figure 2 shows an example of a solution according to the invention: the actual pressure in the joint is estimated based on the data of the pressure sensor in the hose using the Kalman filter. Detected deviations of the measured pressure from the estimated pressure are incorporated into the mathematical model using the so-called Kalman Gains and used for the further estimation. Furthermore shows Figure 2 the equations of state used for this model.
  • the practical implementation of the above-mentioned method is expediently carried out on a microcontroller which is part of the medical device. This is usually equipped with inputs and outputs as well as memories.
  • the mathematical operations are processed in the form of a software module.
  • a flowchart of the software module is in the Figure 3 shown.
  • the software can be stored on its own memory chip, for example an EPROM.
  • Figure 4 shows the results obtained. In the upper figure the measured with the estimated sensor pressure and in the middle figure the measured with the estimated joint pressure is compared. In the Figure 4 The curves shown show a control process, the joint pressure reconstructed by the Kalman filter being used as the control variable. The middle figure shows that the estimated joint pressure is almost identical to the measured one. The lower figure shows the liquid discharge estimated by the Kalman filter.
  • FIG. 5 shows result of comparative measurements presented.
  • two medical pumps were compared. This is a classic peristaltic pump with a pressure sensor in the supply line (identified as A114) and a pump according to the invention with a mathematical estimation system, which receives the pressure of a pressure sensor measured in the supply line as an input variable (identified as A124). Both pumps were connected to a dummy, which simulates the conditions in an actual body cavity. The values actually measured within the dummy by a separate sensor are shown.
  • a set pressure of 70 mmHg was set on both pumps (identified as "set value"), with pressure fluctuations of ⁇ 10 mmHg being regarded as acceptable (identified as "upper ranks” or “lower ranks”).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Instruments For Viewing The Inside Of Hollow Bodies (AREA)
  • Endoscopes (AREA)

Claims (3)

  1. Dispositif médical pour l'introduction de fluides dans des cavités corporelles, comportant
    une pompe à fluides commandable,
    une conduite d'alimentation pour l'introduction d'un fluide dans une cavité corporelle,
    un capteur de pression dans la conduite d'alimentation,
    une deuxième conduite pour l'évacuation du fluide de la cavité corporelle,
    au moins un microprocesseur, au moins une mémoire, et au moins un logiciel,
    le capteur de pression mesurant la pression dans la conduite d'alimentation et la mettant à la disposition du logiciel comme variable d'entrée,
    caractérisé en ce que le logiciel décrit un système d'estimation mathématique, qui décrit mathématiquement un espace d'état estimant la pression actuelle dans la cavité corporelle et commande, au moyen de cette valeur estimée, la puissance de pompage de la pompe à fluides,
    dans lequel le système d'estimation mathématique compris dans le logiciel est configuré de façon d'un filtre de Kalman.
  2. Dispositif médical pour l'introduction de fluides dans des cavités corporelles selon la revendication 1, caractérisé en ce que le fluide est un gaz.
  3. Dispositif médical pour l'introduction de fluides dans des cavités corporelles selon la revendication 1, caractérisé en ce que le fluide est un liquide.
EP15720586.5A 2014-03-28 2015-03-30 Dispositif pour le réglage de la pression interne du corps lors de l'utilisation d'une pompe médicalisée Active EP3122231B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014004480.7A DE102014004480B4 (de) 2014-03-28 2014-03-28 Verfahren und Vorrichtung zur Regelung des Körperinnendrucks bei Verwendung einer medizintechnischen Pumpe
PCT/DE2015/000152 WO2015144120A1 (fr) 2014-03-28 2015-03-30 Procédé et dispositif pour le réglage de la pression interne du corps lors de l'utilisation d'une pompe médicalisée

Publications (2)

Publication Number Publication Date
EP3122231A1 EP3122231A1 (fr) 2017-02-01
EP3122231B1 true EP3122231B1 (fr) 2020-03-11

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ID=53052638

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EP15720586.5A Active EP3122231B1 (fr) 2014-03-28 2015-03-30 Dispositif pour le réglage de la pression interne du corps lors de l'utilisation d'une pompe médicalisée

Country Status (7)

Country Link
US (1) US20160101247A1 (fr)
EP (1) EP3122231B1 (fr)
JP (1) JP6587069B2 (fr)
CN (1) CN106255523B (fr)
DE (1) DE102014004480B4 (fr)
ES (1) ES2795327T3 (fr)
WO (1) WO2015144120A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102016011819A1 (de) 2016-10-05 2018-04-05 W.O.M. World Of Medicine Gmbh Verfahren und Vorrichtung zur intraoperativen Bestimmung der Widerstandsbeiwerte von verschiedenen medizinischen Instrumenten bei der Verwendung einer medizintechnischen Fluidpumpe
US10695511B2 (en) * 2017-09-07 2020-06-30 Conmed Corporation Method for calibrating performance range of a pneumatically sealed trocar
DE102018005314A1 (de) * 2018-07-05 2020-01-09 W.O.M. World Of Medicine Gmbh lnsufflationsvorrichtung mit intelligenter Steuerung der Rauchgasabsaugung

Citations (10)

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Publication number Priority date Publication date Assignee Title
EP0529902B1 (fr) 1991-08-21 1999-02-10 Smith & Nephew, Inc. Système de contrÔle de fluides
EP0868204B1 (fr) 1995-11-22 2003-04-09 Storz Endoskop GmbH Dispositif pour insuffler du gaz dans une cavite du corps d'un etre humain ou animal
US20040039243A1 (en) 2002-08-21 2004-02-26 Gill Bearnson Rotary blood pump diagnostics and cardiac output controller
US20050085799A1 (en) 2003-06-12 2005-04-21 Oded Luria Emergency medical kit, respiratory pump, and face mask particularly useful therein
US20080154185A1 (en) 2006-12-20 2008-06-26 Blight David D Dual pump irrigation/aspiration system and method for determining joint pressure
US20100094113A1 (en) * 2008-10-09 2010-04-15 Mark Ries Robinson Hemodynamic monitoring during automated measurement of blood constituents
US20120283691A1 (en) 2011-05-05 2012-11-08 Carefusion 303, Inc. Automated pressure limit setting method and apparatus
WO2013000777A1 (fr) 2011-06-30 2013-01-03 Gambro Lundia Ab Filtrage d'un signal de pression dépendant du temps
US20130060152A1 (en) 2010-04-28 2013-03-07 Cardiostar, Inc. Apparatus and method for continuous oscillometric blood pressure measurement
DE102011016804B4 (de) 2011-04-12 2016-01-28 Drägerwerk AG & Co. KGaA Vorrichtung und Verfahren zur Datenverarbeitung physiologischer Signale

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Publication number Priority date Publication date Assignee Title
EP0529902B1 (fr) 1991-08-21 1999-02-10 Smith & Nephew, Inc. Système de contrÔle de fluides
EP0868204B1 (fr) 1995-11-22 2003-04-09 Storz Endoskop GmbH Dispositif pour insuffler du gaz dans une cavite du corps d'un etre humain ou animal
US20040039243A1 (en) 2002-08-21 2004-02-26 Gill Bearnson Rotary blood pump diagnostics and cardiac output controller
US20050085799A1 (en) 2003-06-12 2005-04-21 Oded Luria Emergency medical kit, respiratory pump, and face mask particularly useful therein
US20080154185A1 (en) 2006-12-20 2008-06-26 Blight David D Dual pump irrigation/aspiration system and method for determining joint pressure
US20100094113A1 (en) * 2008-10-09 2010-04-15 Mark Ries Robinson Hemodynamic monitoring during automated measurement of blood constituents
US20130060152A1 (en) 2010-04-28 2013-03-07 Cardiostar, Inc. Apparatus and method for continuous oscillometric blood pressure measurement
DE102011016804B4 (de) 2011-04-12 2016-01-28 Drägerwerk AG & Co. KGaA Vorrichtung und Verfahren zur Datenverarbeitung physiologischer Signale
US20120283691A1 (en) 2011-05-05 2012-11-08 Carefusion 303, Inc. Automated pressure limit setting method and apparatus
WO2013000777A1 (fr) 2011-06-30 2013-01-03 Gambro Lundia Ab Filtrage d'un signal de pression dépendant du temps

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Also Published As

Publication number Publication date
JP2017518776A (ja) 2017-07-13
CN106255523A (zh) 2016-12-21
DE102014004480B4 (de) 2017-11-09
DE102014004480A1 (de) 2015-10-01
EP3122231A1 (fr) 2017-02-01
CN106255523B (zh) 2022-05-17
US20160101247A1 (en) 2016-04-14
JP6587069B2 (ja) 2019-10-09
WO2015144120A1 (fr) 2015-10-01
ES2795327T3 (es) 2020-11-23

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